755nm Alex Laser for Treatment of Stretch Marks

• 755nm Alexandrite Laser (Device): 755nm Alexandrite laser with array handpiece

Primary outcomes

• Photographic Evaluation of Striae Clearance [Follow Up Between 1 and 3 Months Post Last Treatment]: The physician will judge the overall improvement by selecting from improvement ranges of 0-25%, 25-50%, 50-75%, or 75-100% clearance when compared to the baseline.

Sex: All, ages: 18 Years to 85 Years

Inclusion Criteria

1. Is a healthy male or female between 18 and 85 years old.
2. Has unwanted striae and wishes to undergo laser treatments to remove or improve them.
3. Is willing to consent to participate in the study.
4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.

Exclusion Criteria

1. Is hypersensitive to light exposure.
2. Has active localized or systemic infection.
3. Is taking medication(s) for which sunlight is a contraindication.
4. Has a history of squamous cell carcinoma or melanoma.
5. Has a history of keloid scarring.
6. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
7. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
8. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
9. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine.
10. Has any other reason determined by the physician to be ineligible to participate in the study.

Participant flow

Outcome results

• Photographic Evaluation of Striae Clearance (Primary), Count of units, areas with striation: 755nm Alexandrite Laser With Array Handpiece 36

Adverse events

Time frame: Adverse events, whether serious or non-serious, were followed throughout study completion, about 18 months.

Other adverse events by term

• Patricia Krantz, Study director, Cynosure, Inc.